FDA Expands Indication, Adds Boxed Warning for HCV Drug

Update to the Technivie label was a result of data from the AGATE-1 trial, which included 120 patients with HCV genotype 4 infection.

The Food and Drug Administration (FDA) has approved an expanded indication for Technivie (ombitasvir, paritaprevir, ritonavir; AbbVie) to include patients with chronic hepatitis C virus (HCV) infection genotype 4 with compensated cirrhosis. Prior to this approval, Technivie was approved for use in chronic HCV genotype 4 infection without cirrhosis, in combination with ribavirin.

The label for Technivie has been updated based on the data from the AGATE-1 trial (n=120) in HCV genotype 4 infected adults with compensated cirrhosis who were treatment-naive or pegylated interferon/ribavirin treatment-experienced.

For HCV genotype 4 patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), Technivie with ribavirin should be administered for 12 weeks. Technivie without ribavirin for 12 weeks may be considered for treatment-naive patients without cirrhosis or for those who cannot take or tolerate ribavirin.

In addition, a boxed warning has been added to the prescribing information stating that patients should be tested for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Technivie. HBV reactivation has been reported in HCV/HBV coninfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases had resulted in fulminant hepatitis, hepatic failure, and death. Patients with HCV/HBV coninfection should be monitored for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Appropriate management of HBV infection should be started as clinically indicated.